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Details

Senior Regulatory Officer


Reference:AWHE-878646 Location: Dublin
Qualification:DegreeExperience:3-4 Years
Job Type:Fixed Term ContractSalary: Not Disclosed

Senior Regulatory Officer
Our client, a global healthcare organisation, requires a Senior Regulatory Officer to join their team. This is an excellent opportunity to work within the growing biologics space in Ireland.

Responsibilities
• Execute operational labelling activities required for all generic and brand products for multiple product types
• Ensure appropriate key goals are met on time, and maintain Compliance of regulatory based labelling: Summary of Product characteristics, Package leaflet and Prescribing Information
• Maintain current knowledge of labelling regulations and guidance
• Collaborate with regional regulatory, medical, clinical and Pharmacovigilance teams to provide labelling advice and support
• Collaborate with regulatory team to author and prepare submission documents
• Collaborate with regulatory team to ensure all documentation is in compliance with eCTD standards
• Perform data entry to ensure regional regulatory compliance for assigned products within regulatory databases and change management system
• Ensure prompt resolution of regulatory issues
• Review of product information and promotional material prior to release
• Maintain awareness of current and new legislation/guidance and ensure that work is in compliance with requirements

Requirements
• Life Science Degree or equivalent experience
• 3-5 years’ experience in a regulatory environment
• Knowledge of regulatory requirements for medicines in EU/Ireland
• Strong demonstrable capabilities in the use of software applications.
• Must possess organization skills, time management skills and attention to detail.
• Excellent team working and communication skills
• Ability to thrive in a changing environment and to re-prioritise workload to meet business needs


If you would like further Information you can contact the recruiter directly:

Sinead Cullen | Tel: +353 (0) 1 507 9252